孙梦华 吕健 黎元元 谢雁鸣 于丹丹

摘要 目的：對疏风解毒胶囊治疗慢性阻塞性肺疾病急性加重期（Acute Exacerbation of Chronic Obstructive Pulmonary Disease，AECOPD）的疗效及安全性进行系统评价。方法：选取国家知识基础设施数据库、中国学术期刊数据库、中文科技期刊数据库、Sinomed、Embase、Medline、Cochrane Library等中英文数据库进行全面系统检索，筛选出疏风解毒胶囊治疗AECOPD的随机对照试验（Randomized Controlled Trials，RCTs），检索时限为各数据库建库至2019年5月。按照预先设定的纳入标准和排除标准，由2位研究者独立进行筛选文献、提取资料，并结合“Cochrane偏倚风险评估”工具对纳入的RCTs进行质量评价，且对纳入的研究使用RevMan 5.3软件进行Meta分析。结果：最终纳入13篇RCTs，包括989例患者，其中观察组（西医常规治疗+疏风解毒胶囊）494例，对照组（西医常规治疗）495例。Meta分析结果显示：观察组总有效率优于对照组（RR=1.25，95%CI为1.16～1.35，P<0.000 01），更能提高氧分压（MD=5.65，95%CI为4.22～7.07，P<0.000 01），降低二氧化碳分压（MD=-2.70，95%CI为-3.88～-1.53，P<0.000 01），并且降低炎症介质水平，包括IL-8（MD=-8.29，95%CI为-9.48～-7.10，P<0.000 01）和TNF-α（MD=-6.30，95%CI为-7.11～-5.49，P<0.000 01）;不良反应方面，观察组与对照组差异无统计学意义（OR=1.43，95%CI为0.44～4.61，P=0.55）。结论：基于现有证据，疏风解毒胶囊联合西医常规治疗可以提高AECOPD的临床疗效，且未发生严重不良反应。但由于纳入研究质量普遍偏低且数量少，以及存在发表性偏倚等诸多局限性，影响结论的可靠性，故其有效性和安全性尚需更多设计严谨、高质量的RCTs去提高证据质量级别。

关键词 疏风解毒胶囊;慢性阻塞性肺疾病;急性加重期;随机对照试验;有效性;安全性;Meta分析;系统评价

Meta-analysis of the Curative Effects of Shufeng Jiedu Capsules in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

SUN Menghua，LYU Jian，LI Yuanyuan，XIE Yanming，YU Dandan

（Institute of Basic Medical Science，China Academy of Traditional Chinese Medicine，Beijing 100700，China）

Abstract Objective：To evaluate the efficiency and the safety of Shufeng Jiedu Capsules for treating acute exacerbation of chronic obstructive pulmonary disease（AECOPD）.Methods：A comprehensive and systematic search was carried out in 7 Chinese and English databases in CNKI，VIP，Wanfang，Sinomed，Embase，Medline，and Cochrane Library，and the randomized controlled trial（RCT）of Shufeng Jiedu Capsules in the treatment of AECOPD was screened.The search time limit was from the establishment of each database to May 2019.According to the pre-set inclusion and exclusion criteria，a total of 2 researchers independently screened the literature，extracted data，evaluated the quality of the included RCTs combined with the “Cochrane Bias Risk Assessment” tool，and RevMan 5.3 software was used for the included studies to perform Meta quantitative analysis.Results：A total of 13 RCTs involving 989 patients were included.Among them，there were 494 cases in the test group（conventional Western medicine treatment+Shufeng Jiedu Capsules）and 495 cases in the control group（conventional Western medicine treatment）.Meta-analysis results indicated that the test group was superior to the control group in total efficacy [RR=1.25，95%CI（1.16 to 1.35），P<0.000 01]，increasing PaO2 [MD=5.65，95%CI（4.22 to 7.07），P<0.000 01]and reducing PaCO2 [MD=-2.70，95%CI（-3.88 to -1.53），P<0.000 01]，and decreased the level of inflammatory factors including IL-8 [MD=-8.29，95%CI（-9.48 to -7.10），P<0.000 01]，TNF-α（TNF-α）[MD=-6.30，95%CI（-7.11 to -5.49），P<0.000 01].There was no significant difference in adverse reactions between the test group and the control group [OR=1.43，95%CI（0.44 to 4.61），P=0.55].Conclusion：Based on available evidence，Shufeng Jiedu Capsules combined with conventional Western medicine treatment can improve the clinical efficacy of AECOPD，without serious adverse reactions.However，because the quality of the included studies is generally low and the number is small，and there are many limitations such as publication bias，which affects the reliability of the conclusions.Thus its effectiveness and safety still need more rigorous design and high-quality RCT tests to improve the evidence quality level.

Keywords Shufeng Jiedu Capsules; Chronic obstructive pulmonary disease; Acute exacerbation; RCT; Effectiveness; Safety; Meta-analysis; Systematic review

中图分类号：R289.5;R563文献标识码：Adoi：10.3969/j.issn.1673-7202.2021.09.014

慢性阻塞性肺疾病急性加重期（Acute Exacerbation of Chronic Obstructive Pulmonary Disease，AECOPD）简称慢阻肺急性加重期，发病特点多为起病急且病情重，呼吸困难、咳嗽、痰量增加甚至出现脓性痰是AECOPD常见的临床表现，与日常症状有很大不同，并且需要更换药物、改变治疗方法[1-2]。AECOPD是中老年人多发的呼吸系统疾病之一，其发病率和死亡率都较高，但治愈率却偏低。有研究表明，本病发病和急性加重的最主要机制是气道慢性非特异性炎症反应，有多种炎症介质参与[3]。虎杖、连翘、板蓝根、柴胡、败酱草、马鞭草、芦根、甘草是疏風解毒胶囊的主要组成成分，具有祛风清热，解毒利咽的功效。……